FDA raises questions about clinical data on Datscan

張貼者:2009年8月10日 上午7:57林昆儒   [ 已更新 2009年8月10日 上午8:01 ]

臨床試驗的程序嚴謹非常重要! 一個大廠的產品,很可能因為一個小插曲而整個改觀!

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

 

WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration on Friday questioned clinical data involving a proposed GE Healthcare imaging agent that would be used in brain scans to help diagnose certain neurological disorders.

The imaging agent, Datscan, faces a review by an FDA panel of outside medical experts next Tuesday. The product is designed to detect the loss of a type of neuron known as a nigrostriatal neuron in the brain and can help diagnose or rule out disorders like Parkinson's disease. The test, however, doesn't directly diagnose such neurological conditions.

The FDA, in a review of the product posted to its Web site Friday, is questioning the data partly because of changes made during the clinical studies that differed from the original design.

The FDA, in a review of the product posted to its Web site Friday, is questioning the data partly because of changes made during the clinical studies that differed from the original design.
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